Pilot Study Evaluating Somatostatin Receptor's PET Imaging to Detect Inflammatory Phases of Myocarditis

NCT03347760 | Completed

• 1 other identifier: 2019-002716-43
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Infectious myocarditis are frequent, most of the time viral and can evolve to cardiac insufficiency. The diagnosis is difficult because they can mime an acute coronary syndrome. Approximately 10 % of patients with acute infarction suspected, have a normal angiography, and half of them has in fact a myocarditis, as showed studies of cardiac MRI among which some realized in our department . However, anomalies observed in MRI are not specific and it is necessary to use multiple criterions. A new radiopharmaceutical, the 68Ga-DOTATOC, specific of somatostatin's receptors which are over expressed by the inflammatory cells, has recently showed the capacity to identify myocarditis, but only in a small group of 6 patients. The investigators make assumptions:

1. 1.this radiopharmaceutical is enough sensitive to detect most of the acute inflammatory myocarditis which are identified by the MRI and
2. 2.it could maybe allow to identify myocarditis with a persistent subacute or chronic inflammation, which are difficult to identify with cardiac MRI, and it would be a new information able to guide the medical decision.

Conditions

Myocarditis

Keywords

68-Ga-DOTATOC PET; Myocarditis

Outcome Measures

Primary Outcomes (1)

• Presence of a significant myocardial retention of 68Ga-DOTATOC during initial staging. Sensibility calculation

  The criterion of positivity will be that of a visually detectable and quantitatively significant area of myocardial uptake, which will be defined by a measurement of the Standardized Uptake Value (SUV) at least 30% higher than that of the blood signal obtained at the center of the left ventricular cavity. This threshold was chosen based on measurements already published in a small pilot study.

  at baseline

Secondary Outcomes (1)

• Frequency of a significant myocardial retention of 68Ga-DOTATOC during initial staging

  6 months

Study Arms (1)

Experimental arm

EXPERIMENTAL

All included patients wil receive 68Ga-dotatoc-PET/CT suspected acute myocarditis in first and an other 68Ga-dotatoc-PET/CT 6 months later

Drug: DOTATOC-68Ga PET initial; Drug: DOTATOC-68Ga PET at 6 months; Biological: blood sample

Interventions

DOTATOC-68Ga PET initial DRUG

DOTATOC is a tracer of high affinity for the type 2 somatostatin receptors and is used for imaging of tumours which are expressing them, including endocrine tumours

Also known as: Imaging PET/CT

Experimental arm

DOTATOC-68Ga PET at 6 months DRUG

DOTATOC is a tracer of high affinity for the type 2 somatostatin receptors and is used for imaging of tumours which are expressing them, including endocrine tumours

Also known as: Imaging PET/CT

Experimental arm

blood sample BIOLOGICAL

blood tests will be carried out during the control visit to ensure that biological parameters are normalized

Experimental arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult subjects who have given their written consent to participate in the study.
• Patients without history of heart disease, hospitalized for acute infarction suspected with positive troponine, normal or subnormal angiography and which have a high probability of acute inflammatory myocardities on the secondarily realized MRI (= 2 criteria of Lake Louise)
• No contraindication to perform a 68Ga-DOTATOC-PET .
• Patient belong to a social security scheme.

You may not qualify if:

• Patients under guardianship or curatorship.
• Pregnancy, breastfeeding and woman of childbearing age without effective contraception
• Impossibility to perform a PET with 68Ga-DOTATOC (patient agitated).
• Impossibility to schedule PET/CT before the deadline = in 7 days since the beginning of the hospitalization.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Véronique ROCH

Vandœuvre-lès-Nancy, 54511, France

Location

Related Publications (1)

• Larive T, Boursier C, Claudin M, Varlot J, Filippetti L, Huttin O, Roch V, Imbert L, Doyen M, Fraix A, Mandry D, Chevalier E, Marie PY. Persistent somatostatin PET signs of inflammatory cells 4 to 5 months after acute myocarditis are linked to a poorer recovery of cardiac function. Eur J Nucl Med Mol Imaging. 2025 Jul;52(9):3395-3403. doi: 10.1007/s00259-025-07202-5. Epub 2025 Mar 22.

  PMID: 40119896 DERIVED

MeSH Terms

Conditions

Myocarditis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Elodie CHEVALIER, MD

  CHRU de NANCY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: November 16, 2017
• First Posted: November 20, 2017
• Study Start: July 13, 2020
• Primary Completion: July 30, 2023
• Study Completion: December 13, 2023
• Last Updated: February 9, 2024

Record last verified: 2024-02

Locations

FR (1)